Real world, open label prospective experience of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) for episodic migraine prophylaxis

Abstract

BackgroundTo investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.MethodsAn observational, prospective, real-world study was conducted. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥ 50% reduction in monthly migraine days at T3, compared to BL were considered Vivinor®-responders.ResultsMean number of migraine days was significantly decreased between BL and T3 (9.9 ± 5.0 vs 6.2 ± 4.0; P < 0.001). Likewise, days with peak headache intensity of > 4/10 (8.3 ± 3.8 vs 5.8 ± 4.0; P < 0.001) as well as days using acute headache medications per month (9.8 ± 5.6 vs 7.2 ± 5.4; P < 0.001) were significantly reduced. At final visit, 64 patients (56.6%) were classified as responders. The beneficial effect of Vivinor® supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores between BL and Τ3. There were no safety concerns.ConclusionsVivinor® appears to be an effective and well-tolerated preventive treatment against episodic migraine.Trial registrationNCT04463875, Registered 9 July 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04463875

The Efficacy of Herbal Supplements and Nutraceuticals for Prevention of Migraine: Can They Help?

“…A significant reduction was evident in the frequency (1.6 vs. 0.5; p < 0.001) and severity of headaches (2.3 vs. 0.6; p < 0.001) among coenzyme Q10 and control groups [ 15 ]. Other pilot studies also showed a reduction in the frequency of migraine attacks with coenzyme Q10 supplementation [ 19 , 22 ].…”